BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 1990688 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-02155
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-02156. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS (OF THE SAME LOT) AND AN IPG, ON (B)(6) 2005. IT WAS REPORTED THE LEADS WERE EXPLANTED AND REPLACED DUE TO INVALID IMPEDANCES ON ALL CONTACTS. DURING THE REVISION, THE PHYSICIAN NOTED SCRATCHES ON THE IPG CAN. AS A RESULT, THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE IPG AS WELL. THE EXPLANTED PRODUCTS WERE DISCARDED BY THE FACILITY. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3146 35270

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention